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PTS Panels® Cholesterol Test Strips

FDA UDI

Class I (US FDA UDI)

by Polymer Technology Systems

Identity

Trade Name
PTS Panels® Cholesterol Test Strips FDA UDI
Generic Name
Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing FDA UDI
Device Name
PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI
Model / Reference
1790 FDA UDI
Description
PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer. FDA UDI

Identifiers

Catalog Number
1790 FDA UDI
Primary DI / UDI-DI
00381931790018 FDA UDI
510(k) Number
K033899 FDA UDI
K990688 FDA UDI
FDA Product Code
CHH FDA UDI
NFX FDA UDI
GMDN Term
Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1175 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing

PTS Panels® Cholesterol Test Strips by Polymer Technology Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total cholesterol lipid IVD, kit, rapid colorimetric, self-testing.

Cleared under the same submission

K990688 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polymer Technology Systems

Sources (1)

  • FDA UDI 82933d28-9c28-40f2-8045-cb4697730457 37 fields · synced Jun 1, 2026